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Indacaterol EfectIveness In COPD Patients With Tuberculosis History (INFINITY)

Primary Purpose

Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Indacaterol
Control
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female adults aged ≥ 19 years in international age
  • Patients with a diagnosis of moderate-to-severe COPD as classified by the GOLD guidelines (2009)
  • Patients with at least one finding of destructed pulmonary parenchyma in the chest X-ray and the sum of all legion volumes equivalent to over 1/3 of one lung
  • Patients with a history of tuberculosis and no change in the chest imaging test over the past one year
  • Patients who can voluntarily sign an Informed Consent Form prior to initiation of any study-related procedure

Exclusion Criteria:

  • Pregnant or nursing (lactating) women

  • Women of childbearing potential not willing to use effective contraception. However, those who have a negative pregnancy test and agree to use effective contraception can participate. Effective contraception does not include periodical abstinence (e.g. basal body temperature, menstrual cycle contraceptive method, etc) but means use of contraception which must include one of barrier contraceptive methods.

    e.g.) condom (barrier contraceptive method), diaphragms (barrier contraceptive method), oral contraceptives, intrauterine device, Depo injection, etc.

  • Patients who have been admitted to hospital for COPD worsening within 6 weeks prior to visit 1
  • Patients with a history of respiratory infection within 6 weeks prior to visit 1
  • Patients requiring long-term oxygen therapy (>15 hours/1 day) for chronic hypoxemia (it is allowed to use up to a total of 10 out of 24 hours on a PRN basis)
  • Patients with a history of asthma
  • Unstable ischaemic heart disease, arrhythmia (except for stable ventricular fibrillation) and uncontrolled hypertension
  • Patients with a history of long QT syndrome or whose QTc interval measured at Visit 2 is prolonged: >450 ms (males) or >470 ms (females)
  • Uncontrolled hypothyroidism and hyperthyroidism
  • Hypokalemia: plasma potassium level < 3.0 mEq/L
  • Patients with creatinine level ≥2 the upper limit of normal
  • Patients with AST/ALT level ≥2 the upper limit of normal
  • Patients with lung cancer or a history of lung cancer
  • Patients with active cancer or a history of cancer with less than 5 years disease-free survival (whether or not there is evidence of local recurrence or metastases; localized basal cell carcinoma of the skin without metastases is acceptable).
  • Patients with a history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
  • Patients who have had live attenuated vaccinations within 30 days prior to Visit 1
  • Patients who have had treatment with investigational drugs, within 30 days or 5 half-lives prior to Visit 1, whichever is longer.
  • Patients unable to successfully use a dry powder inhaler device, metered dose inhaler or perform spirometry measurements
  • Other cases which are considered ineligible for this clinical study by the principal investigator and subinvestigator

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Indacaterol

Placebo

Arm Description

Indacaterol 150 µg once daily

Placebo once daily

Outcomes

Primary Outcome Measures

Trough Forced Expiratory Volume in One Second Change
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariate

Secondary Outcome Measures

St. George Respiratory Questionnaire for COPD (SGRQ-C) Change After 8 Weeks of Treatment
The SGRQ-C contains 14 questions divided into two components. Part 1 produces "Symptoms" scores and Part 2 "Activity" and "Impacts" scores. 14 questions which are divided in three domains: "symptom" (question 1-7), "activity" (question 9, 12) and "impact" (question 8, 10, 11, 13 and 14). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Change From Baseline in Transition Dyspnea Index (TDI) After 8 Weeks of Treatment
TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to 1 hour post inhalation of ipratropium as covariates.
Incidence of COPD Exacerbation
Number of COPD exacerbation during 8-week treatment. COPD exacerbations are defined as a new onset or worsening of at least one respiratory symptom (i.e. dyspnea, cough, sputum purulence or volume, or wheeze) present for at least 3 consecutive days, documented change or increase in COPD-related treatment due to worsening symptoms or documented COPD-related hospitalizations or emergency room visits.

Full Information

First Posted
January 25, 2013
Last Updated
October 1, 2015
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01778062
Brief Title
Indacaterol EfectIveness In COPD Patients With Tuberculosis History
Acronym
INFINITY
Official Title
A Phase Ⅲb, Multicenter, Double-blind, Randomized, Controlled Trial, to Assess the Efficacy and Safety of Indacaterol (150㎍ o.d.) vs. Placebo, in Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical study will assess efficacy and safety of indacaterol (150㎍ o.d.) in patients with Chronic Obstructive Pulmonary Disease (COPD) with destroyed lung by tuberculosis.
Detailed Description
There are few clinical studies in patients with COPD with destroyed lung by tuberculosis because tuberculosis patients are usually excluded from (phase II or III) clinical trials for drug registration although they are not prohibited from prescription of COPD drugs. This clinical study will assess efficacy and safety of indacaterol (150㎍ o.d.) in patients with COPD with destroyed lung by tuberculosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indacaterol
Arm Type
Experimental
Arm Description
Indacaterol 150 µg once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily
Intervention Type
Drug
Intervention Name(s)
Indacaterol
Intervention Description
Indacaterol 150µg once daily oral inhalation
Intervention Type
Drug
Intervention Name(s)
Control
Other Intervention Name(s)
Placebo
Intervention Description
Placebo once daily oral inhalation
Primary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in One Second Change
Description
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariate
Time Frame
8 week
Secondary Outcome Measure Information:
Title
St. George Respiratory Questionnaire for COPD (SGRQ-C) Change After 8 Weeks of Treatment
Description
The SGRQ-C contains 14 questions divided into two components. Part 1 produces "Symptoms" scores and Part 2 "Activity" and "Impacts" scores. 14 questions which are divided in three domains: "symptom" (question 1-7), "activity" (question 9, 12) and "impact" (question 8, 10, 11, 13 and 14). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Time Frame
8 week
Title
Change From Baseline in Transition Dyspnea Index (TDI) After 8 Weeks of Treatment
Description
TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to 1 hour post inhalation of ipratropium as covariates.
Time Frame
8 week
Title
Incidence of COPD Exacerbation
Description
Number of COPD exacerbation during 8-week treatment. COPD exacerbations are defined as a new onset or worsening of at least one respiratory symptom (i.e. dyspnea, cough, sputum purulence or volume, or wheeze) present for at least 3 consecutive days, documented change or increase in COPD-related treatment due to worsening symptoms or documented COPD-related hospitalizations or emergency room visits.
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female adults aged ≥ 19 years in international age Patients with a diagnosis of moderate-to-severe COPD as classified by the GOLD guidelines (2009) Patients with at least one finding of destructed pulmonary parenchyma in the chest X-ray and the sum of all legion volumes equivalent to over 1/3 of one lung Patients with a history of tuberculosis and no change in the chest imaging test over the past one year Patients who can voluntarily sign an Informed Consent Form prior to initiation of any study-related procedure Exclusion Criteria: Pregnant or nursing (lactating) women Women of childbearing potential not willing to use effective contraception. However, those who have a negative pregnancy test and agree to use effective contraception can participate. Effective contraception does not include periodical abstinence (e.g. basal body temperature, menstrual cycle contraceptive method, etc) but means use of contraception which must include one of barrier contraceptive methods. e.g.) condom (barrier contraceptive method), diaphragms (barrier contraceptive method), oral contraceptives, intrauterine device, Depo injection, etc. Patients who have been admitted to hospital for COPD worsening within 6 weeks prior to visit 1 Patients with a history of respiratory infection within 6 weeks prior to visit 1 Patients requiring long-term oxygen therapy (>15 hours/1 day) for chronic hypoxemia (it is allowed to use up to a total of 10 out of 24 hours on a PRN basis) Patients with a history of asthma Unstable ischaemic heart disease, arrhythmia (except for stable ventricular fibrillation) and uncontrolled hypertension Patients with a history of long QT syndrome or whose QTc interval measured at Visit 2 is prolonged: >450 ms (males) or >470 ms (females) Uncontrolled hypothyroidism and hyperthyroidism Hypokalemia: plasma potassium level < 3.0 mEq/L Patients with creatinine level ≥2 the upper limit of normal Patients with AST/ALT level ≥2 the upper limit of normal Patients with lung cancer or a history of lung cancer Patients with active cancer or a history of cancer with less than 5 years disease-free survival (whether or not there is evidence of local recurrence or metastases; localized basal cell carcinoma of the skin without metastases is acceptable). Patients with a history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof. Patients who have had live attenuated vaccinations within 30 days prior to Visit 1 Patients who have had treatment with investigational drugs, within 30 days or 5 half-lives prior to Visit 1, whichever is longer. Patients unable to successfully use a dry powder inhaler device, metered dose inhaler or perform spirometry measurements Other cases which are considered ineligible for this clinical study by the principal investigator and subinvestigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chul-Gyu Yoo, MD PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigative Site
City
Anyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
431-070
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Koyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-773
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Jeonju-si
State/Province
Jeollabuk-do
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
110 744
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Koyang
State/Province
Kyunggi
ZIP/Postal Code
410-719
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
110-102
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
150-713
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of

12. IPD Sharing Statement

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Indacaterol EfectIveness In COPD Patients With Tuberculosis History

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